The main purpose of this study is to see if there is clinical benefit of using Biovance in reduction of the recurrence of keloids when used to revise them. It will also assess the postoperative complications.
To assess the performance of Biovance, patients will consulted regarding the history and previous treatment of their keloid. Once patients are deemed to be appropriate candidates, they will be enrolled in the study. Operatively, the old scar will be completely excised. Then the Biovance will be laid in the base of the wound. After this is performed, extensive undermining will be done to close the wound in layers. All post-revision complications (including infection, incision dehiscence, hematoma, seroma, and wound necrosis) will be assessed and recorded by the investigator. Patients will be reviewed to obtain demographic and risk factor (such as age, body mass index, smoking) data. Data on adjuvant therapy use (previous surgeries, treatments for keloid scar) will be collected. Surgical technique details (such as incision size and closure technique) will also be recorded for each patient. Photographs documenting the pre-, intra- and post-revision clinical course of patients will be collected.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
decellularized, dehydrated human amniotic membrane
Golla Center for Plastic Surgery
Pittsburgh, Pennsylvania, United States
Incidence of keloid scar recurrence after revision surgery with placement of Biovance
Published data in the literature reporting on keloid scar incidence and recurrence without the use of Biovance may serve as a reference/historical control.
Time frame: 1 year post-surgery
Clinical outcomes of keloid scar revision surgery, including scar size and appearance
Time frame: 1 year post-surgery
Incidence of complications (including infection, incision dehiscence, hematoma, seroma, and wound necrosis following revision surgery
Time frame: 1 year post-surgery
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